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Clotrimazole 1%

Clotrimazole USP, 1% Athlete's Foot

Approved
Approval ID

9aba1345-ef47-4951-8448-a43d6696b616

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 7, 2025

Manufacturers
FDA

STRATEGIC SOURCING SERVICES LLC

DUNS: 116956644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70677-1002
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Clotrimazole
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 7, 2025
FDA Product Classification

INGREDIENTS (8)

BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CETYL ESTERS WAXInactive
Code: D072FFP9GU
Classification: IACT
OCTYLDODECANOLInactive
Code: 461N1O614Y
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
CLOTRIMAZOLEActive
Quantity: 10 mg in 1 g
Code: G07GZ97H65
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/19/2023

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Foster & Thrive™

Athlete's Foot Cream

Clotrimazole Cream USP, 1%
ANTIFUNGAL

NET WT 1 OZ (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/19/2023

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/19/2023

**Distributed by:**McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/19/2023

Active ingredient

Clotrimazole 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/19/2023

Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 6/19/2023

Warnings

For external use only

Do not useon children under 2 years of age unless directed by a doctor.

When using this productavoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

**Keep out of reach of children.**If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/19/2023

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/19/2023

Other information

*TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.

  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/19/2023

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/19/2023

Questions?

call833-358-6431

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Clotrimazole 1% - FDA Drug Approval Details